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NCT ID: NCT03675737 Active, not recruiting - Stomach Neoplasms Clinical Trials

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

NCT ID: NCT03675438 Withdrawn - Presbyopia Clinical Trials

Safety and Efficacy of a Sub-epitheilal Transform™ Corneal Allograft (TCA) for Presbyopia Correction

Start date: October 2018
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

NCT ID: NCT03674606 Completed - Pre-Eclampsia Clinical Trials

Trial of Early Screening Test for Pre-eclampsia and Growth Restriction

TEST
Start date: February 1, 2014
Phase: Phase 4
Study type: Interventional

A study of aspirin use in pregnancy to prevent high blood pressure and growth restriction of the fetus

NCT ID: NCT03672058 Recruiting - Cystic Fibrosis Clinical Trials

Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Physical activity is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. The measurement of these behaviours is important in order to monitor prevalence amongst people with CF (PWCF) and determine methods by which health care providers can assist with maintaining and enhancing physical activity. The use of physical activity monitoring can provide health care providers with insightful real world analysis of physical activity and exercise behaviours. Over the last decade there has been many advancements in technology and fitness tracking with positive results being demonstrated in the healthy population and in chronic diseases such as Diabetes Mellitus II, post surgery and Multiple Sclerosis. Limited research has been conducted among PWCF to date. The aim of this research project is to examine physical activity levels amongst PWCF and determine the effect of a 12 week randomised parallel intervention on a number of health outcomes. Participants will be provided with an accelerometer to assess physical activity and sedentary behaviour at baseline. The participants will then undergo further baseline testing to determine exercise capacity, body composition, quality of life, breathlessness, sleep quality and wellbeing. Baseline short and long term goals will be established together with the participant and physiotherapist. Participants will then be randomly allocated to either the intervention or the comparator. A researcher independent of the recruitment process (MC) will complete the first random allocation using a sealed opaque envelope. Following this a minimisation randomisation procedure will be completed based on lung function, where FEV1 of <70% predicted lung function will be classified as having mild lung disease. While those with an FEV1 of 30-50% predicted lung function will be classified as having moderate lung disease, with <30% indicating severe lung disease. Allocation will be revealed after recruitment and baseline assessments have occurred. Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks. The intervention group will receive personalised feedback via a text message every week on their physical activity levels as measured by their fitness tracker and progress on attainment of their goals established at the start of the study. Feedback will be provided from their CF physiotherapists. The comparator group will not receive any feedback on their Fitbit data. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally outcome measures including lung function, physical activity levels, aerobic capacity, quality of life, sleep quality, muscle mass and well-being will be re-assessed again at 24 weeks. Following the intervention semi structured interviews will be conducted to qualitatively establish satisfaction with the interventions and provide insight into barriers and enablers to achieving goals and physical activity levels.The results of this study may provide valuable insights into potential interventions to optimise the health and well-being of PWCF.

NCT ID: NCT03671395 Active, not recruiting - Clinical trials for Musculoskeletal Injury

The DCU Running Injury Surveillance Centre Study: A Prospective Investigation of Factors Relating to Running Injuries

DCU RISC
Start date: February 1, 2018
Phase:
Study type: Observational

This study aims to prospectively investigate the relationship between a number of clinical and biomechanical variables and running-related injuries among a group of novice and recreational runners over a two year time period. To date, the incidence of running injuries among runners is high, with a lack of prospective research investigating the factors related to injury. It is thought that loading in excess of the tissues capabilities may be be a contributing factor to sustaining a running related injury. As such, this study hypothesizes that biomechanical factors may be related to injury. Healthy participants will perform a battery of clinical tests at baseline, as well as completing a survey that details their injury history and training habits. Kinematic and kinetic motion analysis will be used as participants perform a series of functional movements and a treadmill run. Enrolled participants will be monitored for the occurrence of running-related injuries via email for the duration of the study.

NCT ID: NCT03671135 Terminated - Presbyopia Clinical Trials

Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction

Start date: August 9, 2018
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

NCT ID: NCT03671096 Withdrawn - Hyperopia Clinical Trials

Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction

Start date: October 2018
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for improving distance vision in hyperopic subjects. The overall objective with respect to visual outcome is to provide improved vision without the requirement of additional visual aids.

NCT ID: NCT03668964 Completed - Healthy Volunteers Clinical Trials

Effect of Nutrition Ingredients on Microbiota Modulation

VitaGut
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.

NCT ID: NCT03666780 Active, not recruiting - Atrial Fibrillation Clinical Trials

Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study

LISA
Start date: November 16, 2018
Phase:
Study type: Observational

Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.

NCT ID: NCT03657043 Completed - Ovarian Cancer Clinical Trials

A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)

Start date: March 20, 2019
Phase: Phase 2
Study type: Interventional

This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).